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Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke

AssesSment of the Left Atrial Appendage morphoLogy in Patients aAfter ischeMic Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02654795
Acronym
ASSAM
Enrollment
200
Registered
2016-01-13
Start date
2013-08-31
Completion date
2016-07-31
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief summary

Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF). Numerous factors predisposing to peripheral embolism in patients with AF have been well defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation minimizes the risk attributable to known risk factors, stroke may still occur. Thus, unknown risk factors may play an important role in stroke risk stratification in patients with AF. The investigators assume that one of the important unknown risk factor is left atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the time of stroke. The control group will consist of 100 patients scheduled for AF ablation without a history of stroke or TIA.

Interventions

RADIATIONcomputed tomography

CT angiography will be performed with a dual-source CT scanner using prospective ECG gating, with detector collimation of 128x0.6 mm, a gantry rotation time of 280 ms, tube voltage of 100-120 kV, tube current of 280-380 mAs depending on the patient's body mass.

Sponsors

Centre of Postgraduate Medical Education
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* history of ischemic stroke or transient ischemic attack * history of AF/AL * known status of anticoagulation at the time of stroke (treatment dose, INR level)

Exclusion criteria

* hemorrhagic stroke * serious renal impairment with GFR \<30 ml/min * hyperthyroidism * allergy to the contrast agent * mental inability to sign the informed consent * receptive aphasia

Design outcomes

Primary

MeasureTime frameDescription
The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2Through study completion, an average of 1 yearThe investigators will examine association of specific type of LAA morphology with ischemic stroke taking in to account anticoagulation in the time of stroke/TIA. The morphology of LAA will be divided into 4 types: * the chicken wing - LAA with only one lobe, its length exceeds 40 mm and its bend angle is less than 100 degrees * the windsock - LAA with one dominant lobe (length \> 40 mm) and several secondary, or even tertiary ones, its length exceeds 40 mm and its bend angle exceeds 100 degrees * the cauliflower - LAA with a variable number of lobes with lack of a dominant lobe, its total length is less than 40 mm * the cactus - LAA with a dominant central lobe with several secondary ones, its total length less than 40 mm

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026